Multimodality RV Phenotyping for Risk Stratification and Short-Term Outcomes in Group 1 PAH
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa
About this trial
The MIRROR-PAH is a single-center, prospective, observational cohort study evaluating the incremental value of multimodality imaging-derived right ventricular characteristics for risk stratification in patients with Group 1 pulmonary arterial hypertension (PAH). The study aims to determine whether incorporation of echocardiographic and cardiac magnetic resonance (CMR)-derived right ventricular parameters into established non-invasive risk assessment models results in risk reclassification and improves identification of patients at risk for short-term clinical worsening.
Adult patients with established Group 1 PAH undergoing routine follow-up and with available right heart catheterization (RHC) and CMR data will be consecutively enrolled. Clinical, laboratory, echocardiographic, and follow-up data will be prospectively collected over a 6-month period. Associations between multimodality imaging findings, invasive hemodynamic measurements, risk classification, and short-term clinical outcomes will be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older
Diagnosis of Group 1 pulmonary arterial hypertension (PAH) according to ESC/ERS guidelines
Followed at the study center with a diagnosis of PAH
Availability of right heart catheterization (RHC) and cardiac magnetic resonance (CMR) imaging data obtained within a clinically relevant time interval
Disqualifiers
Age younger than 18 years
Pulmonary hypertension groups other than Group 1 PAH (Groups 2-5 PH)
Absence of either right heart catheterization or cardiac magnetic resonance imaging data within a clinically relevant time interval
Incomplete clinical or imaging data preventing analysis
Trial population
Adult patients with established Group 1 pulmonary arterial hypertension (PAH) undergoing routine follow-up at a specialized pulmonary hypertension center. Eligible participants will have available right heart catheterization (RHC), transthoracic echocardiography, and cardiac magnetic resonance (CMR) imaging data and will undergo prospective clinical and echocardiographic follow-up for 6 months.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Patients with Group 1 Pulmonary Arterial Hypertension
Trial outcomes
Primary outcomes
1
Risk reclassification rate after incorporation of multimodality imaging-derived RV characteristics into established non-invasive PAH risk models
The proportion of patients undergoing risk reclassification after incorporation of multimodality imaging-derived right ventricular (RV) characteristics obtained from echocardiography and cardiac magnetic resonance imaging into established non-invasive PAH risk assessment models will be evaluated. Changes in risk category assignment compared with conventional non-invasive risk stratification will be assessed.
Time frame
Baseline and 6-month follow-upSecondary outcomes
1
Number of Participants Experiencing Composite Clinical Worsening
Composite clinical worsening is defined as the occurrence of at least one of the following events during the 6-month follow-up period: pulmonary arterial hypertension (PAH) treatment escalation, PAH-related hospitalization, worsening World Health Organization (WHO) functional class, decline in 6-minute walk distance, or death.
Time frame
6 months2
Change in Predictive Performance for Composite Clinical Worsening After Addition of RV Imaging Characteristics to Conventional PAH Risk Classification
The predictive performance of conventional three-strata pulmonary arterial hypertension risk classification for 6-month composite clinical worsening will be compared with the predictive performance of an imaging-augmented risk classification incorporating predefined right ventricular imaging characteristics. Predictive performance will be assessed using the area under the receiver operating characteristic curve.
Time frame
6 months3
RV imaging characteristics associated with clinical worsening
Multimodality imaging-derived RV characteristics associated with an increased risk of composite clinical worsening will be identified.
Time frame
6 months4
Agreement Between Cardiovascular Magnetic Resonance-Derived Stroke Volume Index and Right Heart Catheterization-Derived Stroke Volume Index
Agreement between stroke volume index (mL/m²) measured by cardiovascular magnetic resonance imaging using ventricular volumetric analysis and stroke volume index (mL/m²) calculated from cardiac output obtained during right heart catheterization will be assessed at baseline using Bland-Altman analysis. The mean difference in stroke volume index (mL/m²) between the two methods will be reported.
Time frame
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Source ClinicalTrials.gov